The Talent Pipeline Program is a one-year comprehensive training and real-world work experience opportunity tailored for recent university graduates. This program is designed to bridge the gap between academic knowledge and professional application, equipping participants with the skills and experience necessary to excel in their careers.
At PTC, we believe in nurturing talent and providing a supportive environment where recent graduates can thrive. The Talent Pipeline Program is our commitment to empowering the next generation and investing in a brighter future for all.
.Job Description:
Job Objective
The Global Regulatory Affairs CMC Fellow will play a key role in supporting regulatory strategy development and execution of RA CMC activities related to Chemistry, Manufacturing and Control (CMC) of assigned program. This internship offers a unique opportunity to gain hands-on experience in Regulatory Affairs (RA), with a specific focus on Regulatory Affairs Chemistry, Manufacturing, and Controls (RA CMC) strategy development. Gain experience in RA and RA-CMC guidance/strategy in Biotech company.
Tasks/Responsibilities
Coordinate regulatory CMC activities such as process improvement initiatives, and team meetings.
Support CMC regulatory lead for submissions in coordination with Technical Operations and Quality in accordance with global regulations and regulatory guidance
Research Regulatory guidance and precedence for drug development, registration, and/or post-approval product life cycle management.
Completing all assigned tasks and assisting with day-to-day operations.
Participating in meetings, workshops, and other learning opportunities.
Observing and learning from experienced staff members.
Gaining knowledge of company policies, protocols, and processes.
Taking detailed notes and liaising with Managers, Supervisors, and other senior staff.
Fulfilling any requirements and meeting goals set out at the start of the Internship.
Following all company regulations, and health and safety codes.
Preparing documents and updating records.
Experience / Qualifications
Bachelor’s degree in life science - Scientific discipline (Biology, chemistry, molecular biology, biomedical engineering)
PharmD, Masters in Pharmaceutical Sciences, or Masters in Regulatory Affairs preferred
Excellent written, verbal, communication and interpersonal skills.
Proficiency in Microsoft Office suite
Superb attention to detail.
A positive attitude and willingness to learn.
Excellent time management skills.
This is a one (1) year Talent Pipeline Program and the candidate/applicant must be able to complete the entire one-year program
Fellow must be a recent college graduate
For consideration, each applicant MUST answer the three (3) questions below in your cover letter to be considered for this one-year PTC Talent Pipeline Program.
Why do you want to be part of this program?
In what ways do you believe you can impact the future?
What interests you most about this opportunity?
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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